Registration Dossier

Administrative data

Description of key information

In vitro skin and eye irritation studies performed in accordance with GLP and recommended guidelines, have shown that Balsalazide acid is not a skin or eye irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14th June 2018 - 17th July 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
Batch: 0400
Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Justification for test system used:
The EpiDerm Skin Model is a well-established organotypic, three-dimensional model of the human epidermis and is used for in vitro experiments since many years. It is known for its similarity to human skin.

Vehicle:
unchanged (no vehicle)
Details on test system:
RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: MatTek
- Tissue lot number: 28623

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 ± 1°C
- Temperature of post-treatment incubation (if applicable): 37 ± 1°C

REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: The tissues were gently rinsed about 20 times with PBS (phosphate buffered saline). Excess PBS was removed by gently shaking the insert and blotting the bottom with blotting paper.
- Observable damage in the tissue due to washing: None reported

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 300 µL of pre-warmed MTT solution was used
- Incubation time: 3 hours
- Spectrophotometer: Plate spectrophotometer
- Wavelength: 570 nm

PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50% or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.]
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%.
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
TEST MATERIAL
- Concentration (if solution): 25 mg + 25 μL H2O

NEGATIVE CONTROL
- Concentration (if solution): 50 μL distilled water

POSITIVE CONTROL
- Concentration (if solution): 50 μL 8 N KOH

Duration of treatment / exposure:
3 min and 60 min exposure time
Duration of post-treatment incubation (if applicable):
3 hours
Number of replicates:
The test was performed on a total of 4 tissues per dose group, 2 replicates for each treatment
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
3 minutes treatment
Value:
112.9
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
60 minutes treatment
Value:
84.8
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: None reported
- Direct-MTT reduction: The test material showed no non-specific MTT- reducing.
- Colour interference with MTT: The test item showed water-colouring potential in Aqua dest. and in isopropanol in the range of 570 ± 30 nm. Therefore, additional viable tissue controls were treated with the test item to determine the non-specific colour (NSCliving) and the results were corrected to the true MTT metabolic conversion (TODTT).

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes - mean absolute OD570 nm for 3 min experiment: 1.651; mean absolute OD570 nm for 60 min experiment: 1.896
- Acceptance criteria met for positive control: Yes - mean relative tissue viability for 60 min experiment: 6.6%
- Acceptance criteria met for variability between replicate measurements: Yes - CV: 4.4 - 12.8%

Table 1: Results of 3 min experiment

Name

Negative control

Test item

Positive control

Tissue

1

2

1

2

1

2

 

Absolute OD570

1.585

1.687

1.926

1.819

0.192

0.161

1.596

1.716

1.920

1.782

0.195

0.161

1.617

1.705

1.896

1.805

0.195

0.168

 

OD570 -

Blank Corrected

1.540

1.642

1.882

1.774

0.148

0.116

1.551

1.671

1.875

1.737

0.150

0.116

1.572

1.660

1.851

1.760

0.150

0.123

Mean OD570 of 3 Aliquots

(Blank Corrected)

1.554

1.658

1.869

1.757

0.149

0.118

SD OD570 of 3 Aliquots

0.016

0.015

0.016

0.019

0.002

0.004

Total Mean OD570 of 2

Replicate Tissues (Blank

Corrected)

 

1.606*

 

1.813

 

0.134

TODTT

 

1.813

 

SD OD570 of 2 Replicate

Tissues

0.073

0.080

0.022

Mean Relative Tissue

Viability [%]

100.0

112.9

8.3

Mean Relative Tissue

Viability [%]

- NSCliving Corrected

-

112.9

-

Coefficient Of Variation

[%]***

4.6

4.4

16.3

* corrected mean OD570 of the negative control corresponds to 100% absolute tissue viability.

*** coefficient of variation (CV) (in the range of 20 – 100% viability) between two tissues treated identically is

≤ 30%.

Table 2: Results of 60 min experiment

Name

Negative control

Test item

Positive control

Tissue

1

2

1

2

1

2

 

Absolute OD570

2.007

1.778

1.747

1.476

0.187

0.148

1.996

1.803

1.760

1.475

0.187

0.151

1.987

1.803

1.763

1.468

0.186

0.148

 

OD570-

Blank Corrected

1.962

1.733

1.702

1.431

0.142

0.104

1.951

1.758

1.715

1.430

0.142

0.106

1.942

1.759

1.719

1.423

0.141

0.104

Mean OD570of 3 Aliquots

(Blank Corrected)

1.952

1.750

1.712

1.428

0.142

0.105

SD OD570of 3 Aliquots

0.010

0.015

0.009

0.004

0.001

0.002

Total Mean OD570of 2

Replicate Tissues (Blank

Corrected)

 

1.851

 

1.570

 

0.123

TODTT

-

1.570

-

SD OD570of 2 Replicate

Tissues

0.143

0.201

0.026

Mean Relative Tissue

Viability [%]

100.0

84.8

6.6**

Mean Relative Tissue

Viability [%]

- NSClivingCorrected

-

84.6

-

Coefficient Of Variation

[%]***

7.7

12.8

21.2

* corrected mean OD570 of the negative control corresponds to 100% absolute tissue viability.

** mean relative tissue viability of the 60 min positive control < 15%,

*** coefficient of variation (CV) (in the range of 20 – 100% viability) between two tissues treated identically is

≤ 30%

Table 3: Result of the NSCliving control at 3 min

NSCliving

TVT

Negative control

Tissue

1

2

1

2

 

absolute OD570 - values

0.047

0.047

1.585

1.687

0.049

0.049

1.596

1.716

0.048

0.048

1.617

1.705

absolute OD570-

Blank corrected values

0.002

0.002

1.540

1.642

0.005

0.004

1.551

1.671

0.003

0.003

1.572

1.660

mean OD570

(mean of 3 aliquots)

0.003

0.003

1.554

1.658

total mean OD570

(mean of replicate

tissues)

 

0.003

 

1.606

SD OD570

(of the 2 replicate

tissues)

0.000

0.073

NSCliving [%]

0.2

-

Relative Tissue Viability

[%]

-

96.8

103.2

Mean Relative Tissue

Viability [%]

-

100.0

SD Tissue Viability [%]

-

4.6

CV [% Viabilities]

-

4.6

Table 4: Result of the NSCliving control at 60 min

NSCliving

TVT

Negative control

Tissue

1

2

1

2

 

absolute OD570 - values

0.048

0.048

2.007

1.778

0.053

0.050

1.996

1.803

0.048

0.048

1.987

1.803

absolute OD570-

Blank corrected values

0.003

0.003

1.962

1.733

0.008

0.005

1.951

1.758

0.003

0.003

1.942

1.759

mean OD570

(mean of 3 aliquots)

0.005

0.003

1.9552

1.750

total mean OD570

(mean of replicate

tissues)

0.004

1.851

SD OD570

(of the 2 replicate

tissues)

0.001

0.143

NSCliving[%]

0.2

-

Relative Tissue Viability

[%]

-

105.4

94.6

Mean Relative Tissue

Viability [%]

-

100.0

SD Tissue Viability [%]

-

7.7

CV [% Viabilities]

-

7.7

The test item showed no non-specific MTT-reducing but water-colouring potential in Aqua dest. And in isopropanol in the range of 570 ± 30 nm . Therefore, additional viable tissue controls were treated with the test item to determine the non-specific colour (NSCliving) and the results were corrected to the true MTT metabolic conversion (TODTT).

  

As NSClivingwas ≤ 5% relative to the negative control of living epidermis, no correction of the results was necessary.

The test item showed no corrosive effects. The mean relative tissue viability (% negative control) was 50% (112.9%) after 3 min treatment and 15% (84.8%) after 60 min treatment.

The controls confirmed the validity of the study. The mean OD570nmof the two negative control tissues was 0.8 and 2.8 for each exposure period. The mean relative tissue viability (% negative control) of the positive control was < 15% (1.896%) after 60 min treatment. The coefficient of variation (CV) (in the range of 20 – 100% viability) of replicate tissues of all dose groups was 30% (4.4% - 12.8%).

Interpretation of results:
GHS criteria not met
Conclusions:
The test item showed no corrosive effects and is therefore classified as 'non-corrosive'.
Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27 November - 21 December 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Version / remarks:
28 July 2015
Qualifier:
according to
Guideline:
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
Version / remarks:
6 July 2012
Qualifier:
according to
Guideline:
other: L'Oreal Standard Operating Procedure:"EpiSkin Test Method";-ECVAM Skin Irritation Validation Study- Validation of the EpiSkin Test Method for the Prediction of Acute Skin Irritation of Chemicals
Version / remarks:
Version 1.8, Feb-2009
Qualifier:
according to
Guideline:
other: ECVAM DB-ALM Protocol No. 131 "EpiSkin Skin Irritation test "
Version / remarks:
9 June 2012
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
Test material: Balsalazide acid
Batch No.: 0400
Description: solid, deep orange, crystalline powder
Storage conditions: Room temperature
Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
other: Adult donors
Justification for test system used:
This test uses the EPISKIN-SM™ reconstructed human epidermis model (SkinEthic) which consists of normal human epidermal keratinocytes (NHEK) and therefore represents in vitro the target organ of the species of interest and closely mimics the biochemical and physiological properties of the upper parts of the human skin, i.e. the epidermis.
Vehicle:
unchanged (no vehicle)
Details on test system:
RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN-SM™
- Lot No.: 18-EKIN-051
- Expiry date: 24 December 2018

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: Room temperature
- Temperature of post-treatment incubation: 37 ± 1°C

REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: The tissues were washed with DPBS to remove any residual test item and excess DPBS was removed by blotting bottom with blotting paper.
- Observable damage in the tissue due to washing: None reported

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 2 mL of 0.3 mg/mL MTT
- Incubation time: 3 hours ± 5 minutes
- Spectrophotometer: Plate spectrometer
- Wavelength: 570 nm
- Filter: Yes
- Filter bandwidth: ± 30 nm

NUMBER OF REPLICATE TISSUES: 3

CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Not required

PREDICTION MODEL / DECISION CRITERIA
- The test item is considered to be irritant to skin if the tissue viability after 15 min of exposure and 42 h of post-incubation is less or equal to 50%.
- The test substance may be considered as non-irritant to skin if the tissue viability after exposure and post-treatment incubation is higher than 50%.
Control samples:
yes, concurrent negative control
yes, concurrent positive control
yes, concurrent MTT non-specific colour control
Amount/concentration applied:
TEST MATERIAL
- 10 ± 2 mg + 5 µL aqua dest.

NEGATIVE CONTROL
- 10 µL Dulbecco's Phosphate Buffering Saline

POSITIVE CONTROL
- 10 µL 5% sodium dodecyl sulfate

The test was performed on a total of 3 tissues per dose group.
Duration of treatment / exposure:
15 ± 0.5 minutes
Duration of post-treatment incubation (if applicable):
42 ± 1 hour plus 3 hour MTT incubaton period
Number of replicates:
Three
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Mean
Value:
98.5
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Other effects / acceptance of results:
The mixture of 10 mg test item per 2 mL MTT medium showed no reduction of MTT as compared to the solvent. The mixture did not turn blue/purple. Therefore, NSMTT (non-specific reduction of MTT) equalled 0%.

The mixtures of 10 mg of the test item per 90 µL aqua dest. and per 90 µL isopropanol showed colouring detectable by unaided eye-assessment but the chemical in water and/or isopropanol did not absorb light in the range of 570 ± 30 nm. Therefore, NSCliving (non-specific colour of additional viable tissues) equalled 0%.

The test item showed no non-specific reduction of MTT and no relevant colouring potential after mixture with aqua dest. and with isopropanol. Therefore, no additional controls for correction of possible false-negative results were necessary.

The test item showed no irritant effects. The mean relative tissue viability (% negative control) was > 50% (98.5%) after 15 min treatment and 42 h post-incubation.

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes: Mean Absolute OD570 nm = 0.967
- Acceptance criteria met for positive control: Yes: Mean relative viability (%) = 3.4
- Acceptance criteria met for variability between replicate measurements: Yes: Max. SD of % viability (%) = 10.1
- Range of historical values if different from the ones specified in the test guideline:

Table 1: Result of the Test Item Balsalazide acid

Name

Negative Control

Positive Control

Test Item

Replicate Tissue

1

2

3

1

2

3

1

2

3

Absolute OD570

0.856

0.975

1.043

0.072

0.076

0.067

0.946

0.908

1.059

0.877

0.992

1.060

0.070

0.081

0.070

0.961

0.898

0.950

Mean Absolute OD570

0.967****

0.073

0.954

OD570(Blank Corrected)

0.815

0.934

1.002

0.031

0.035

0.026

0.905

0.867

1.018

0.836

0.951

1.019

0.029

0.040

0.029

0.920

0.857

0.909

Mean OD570of the Duplicates
(Blank Corrected)

0.825

0.943

1.011

0.030

0.037

0.027

0.913

0.862

0.964

Total Mean OD570of the 3 Replicate Tissues (Blank Corrected)

0.926*

0.032

0.913

SD of Mean OD570of the Duplicates (Blank Corrected)

0.094

0.005

0.051

Relative Tissue Viability [%]

89.1

101.8

109.1

3.2

4.0

3.0

98.5

93.0

104.0

Mean Relative Tissue Viability [%]

100.0

3.4**

98.5

SD of Relative Tissue Viability [%]***

10.1

0.6

5.5

CV [% Viabilities]

10.1

16.4

5.6

*                 Corrected mean OD570of the negative control corresponds to 100% absolute tissue viability.

** Mean relative tissue viability of the three positive control tissues is£ 40%

  

***          Standard deviation (SD) obtained from the three concurrently tested tissues is 18%.

****        The mean absolute OD570of the negative control is≥ 0.6 and ≤ 1.5.

 

Interpretation of results:
GHS criteria not met
Conclusions:
In this study under the given conditions the test item showed no irritant effects. The relative mean tissue viability after 15 min of exposure and 42 h post-incubation was > 50%. The test item, balsalazide acid, is therefore classified as “non-irritant” to skin.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 November 2018 - 13 February 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
Test material: Balsalazide acid
Batch No.: 0400
Description: solid, deep orange, crystalline powder
Storage conditions: Room temperature
Details on test animals or tissues and environmental conditions:
- Tissue source: The assay used isolated corneas obtained as a by-product from animals freshly slaughtered at the abattoir A. Moksel AG, Buchloe, Germany.
Vehicle:
physiological saline
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 750 µL of the test item preparation or the control substance
- Concentration: The test item was suspended with physiological saline 0.9% NaCI to give a 20% concentration.
Duration of treatment / exposure:
4 hours ± 5 minutes incubation at 32 ± °C
Duration of post- treatment incubation (in vitro):
90 minutes at 32 ± 1°C
Number of animals or in vitro replicates:
Three corneas were tested for the test item, negative control and positive control.
Details on study design:
SELECTION AND PREPARATION OF CORNEAS
On the test day, fresh eyes were collected from the slaughterhouse and were transported in HBSS containing Pen/Strep on ice to the laboratories. Immediately after arrival of the eyes, cornea preparation was initiated.
The eyes were carefully examined for defects and any defective eyes were discarded.
The tissue surrounding the eyeball was carefully pulled away and the cornea was excised leaving a 2 to 3 mm rim of sclera. The isolated corneas were stored in a petri dish containing HBSS.

QUALITY CHECK OF THE ISOLATED CORNEAS
Before the corneas were mounted in corneal holders with the endothelial side against the 0-ring of the posterior chamber, they were visually examined for defects and any defective cornea were discarded.

NUMBER OF REPLICATES
Three replicates per test substance or control.

NEGATIVE CONTROL USED
Physiological saline 0.9% NaCI

POSITIVE CONTROL USED
Imidazole 20% in physiological saline 0.9% NaCI

APPLICATION DOSE AND EXPOSURE TIME
750 µL of the test item preparation or the control substance was introduced into the anterior chamber (closed-chamber method). After 4 hours ± 5 minutes incubation at 32 ± 1 °C either the test substance or the control substance was removed.

TREATMENT METHOD: closed chamber

REMOVAL OF TEST SUBSTANCE
The epithelium was washed at least three times with MEM (minimum essential medium) (containing phenol red). Once the medium was free of test substance, the cornea was finally rinsed with complete RPMI (Roswell Park Memorial Institute) 1640 medium (without phenol red).

POST-EXPOSURE INCUBATION: The posterior chamber was refilled with fresh complete RPMI 1640 medium. 1 mL of a 5 mg/mL sodium fluorescein solution was added to the anterior chamber and the corneas were incubated for 90 minutes at 32 ± 1°C.

METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity : The change in opacity for each cornea was calculated by subtracting the initial opacity reading from the final opacity reading. These values were corrected by subtracting from each the average change in opacity observed for the negative-control corneas. The mean opacity value for each treatment was calculated by averaging the corrected opacity values of each cornea for a given treatment.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of UV/VIS spectrophotometry (OD490)
- Others: After the initial incubation period, each cornea was observed visually and pertinent observations were recorded.

SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
IVIS = mean opacity value + (15 x mean permeability OD490 value)

DECISION CRITERIA: As indicated in the guideline
Irritation parameter:
in vitro irritation score
Run / experiment:
Mean
Value:
0.27
Vehicle controls validity:
not examined
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Other effects / acceptance of results:
The mean in vitro irritation score for Balsalazide acid was 0.27.

OTHER EFFECTS:
- Visible damage on test system: All 3 corneas treated with Balsalazide acid showed a slight yellowish discolouration of the edges of the tissue.

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The negative control responses in the 2nd experiment resulted in opacity and permeability values that were less than the established upper limits for background bovine corneas treated with the respective negative control.
- Acceptance criteria met for positive control: In the 2nd experiment the in vitro Irritation score obtained with the positive ontrol fell within the two Standard deviations of the current historical mean and therefore this assay was considered to be valid.
- Range of historical values if different from the ones specified in the test guideline: Mean IVIS value (MV) = 122.15; Standard deviation (SD) = 18.00; MV-2xSD = 86.16; MV+2xSD = 158.14 (number of measurements = 40)

Due to the fact that the IVIS of the positive control did not fall within the two Standard deviations of the current historical mean in the 1st experiment, this experiment was considered to be not valid according to the study acceptance criteria stated in the guideline. Therefore, the experiment was repeated and all data reported here refers to the second experiment.

Table 1: Opacity results

Cornea No.

Test item

Initial opacity

Final opacity

Change of opacity value

Corrected opacity value

1

Negative control

2.21

3.16

0.95

 

2

2.06

2.35

0.29

 

3

2.31

2.68

0.36

 

MV

2.19

2.73

0.53

 

4

Positive control

2.97

88.54

85.56

85.03

5

3.16

99.17

96.01

95.48

6

2.79

90.25

87.46

86.93

MV

2.97

92.65

89.68

89.15

7

Test item

0.79

1.40

0.61

0.08

8

2.71

3.50

0.79

0.25

9

0.65

1.67

1.02

0.49

MV

1.38

2.19

0.81

0.27

MV = mean value

 

Table 2: Permeability results:

Cornea No.

Test item

OD490

Corrected OD490 value

1

Negative control

0.009

 

2

0.014

 

3

0.023

 

MV

0.015

 

4

Positive control

1.378

1.363

5

2.000

1.985

6

2.185

2.170

MV

1.854

1.839

7

Test item

0.010

-0.005

8

0.027

0.012

9

0.009

-0.006

MV

0.015

0.000

MV = mean value

 

Table 3: In vitro irritation score

Cornea No.

Test item

Corrected opacity value

Corrected OD490 value

IVIS

1

Negative control

0.95

0.009

 

2

0.29

0.014

 

3

0.36

0.023

 

MV

0.53

0.015

0.76

4

Positive control

85.03

1.363

 

5

95.48

1.985

 

6

86.93

2.170

 

MV

89.15

1.839

116.73

7

Test item

0.08

-0.005

 

8

0.25

0.012

 

9

0.49

-0.006

 

MV

0.27

0.000

0.27

MV = mean value

Interpretation of results:
GHS criteria not met
Conclusions:
According to the evaluation criteria of the test guideline, the test item, Balsalazide acid, does not require classification as corrosive to eyes or as an eye irritant.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

The in vitro skin corrosion and skin and eye irritation studies performed in accordance with OECD Guidelines 431, 439 and 437, respectively, show that Balsalazide acid is not corrosive or irritating. Therefore, in accordance with Regulation (EC) No. 1272/2008, Balsalazide acid does not require classification as corrosive or as a skin or eye irritant.